3 General requirements for the performance evaluation
3.1 Responsibilities and resources
The manufacturer takes the responsibility for the initiation and/or the conduct of a performance evaluation study. He shall define the responsibility and the interrelation of all personnel who manage
and conduct the performance evaluation of IVD MDs, particularly for personnel who need the
organisational freedom and authority to
a) asss the validity of test results and data already available;
b林峰女友
) specify performance claims which shall be further examined or confirmed;
c) specify and document the evaluation plan and the test procedures;
d) prepare the evaluation report.
The manufacturer shall appoint a co-ordinator with overall responsibility of the performance evaluation
study. The co-ordinator shall himlf assure that adequate resources are available. The investigator
shall ensure that the evaluation plan is followed at his location and that the study is appropriately
reviewed from an ethical point of view.
3.2 Documenta最大的螳螂
tion
The documentation of the performance evaluation study shall contain the files relating to claus 3 to
7 of this standard and shall be part of the technical documentation of the IVD MD.
3.3 Final asssment and review
The co-ordinator shall asss and document which performance claims are met, state whether claims
are not met and give recommendations for corrective actions, where necessary.
The responsible management of the manufacturer shall make sure that the results of the performance
evaluation study and the recommendations for corrective actions are carefully considered and properly
documented before issuing a declaration of conformity.
4 Organisation of a performance evaluation study
4.1 Preconditions
Before starting a performance evaluation study it shall be ensured by the co-ordinator that
a) the performance claims of the IVD MD which are the subject of the study are specified;
b) the IVD MD has been manufactured under controlled production process and conditions;
c) the IVD MD to be evaluated meets the quality control relea specifications;
d) a sufficient number of samples of the IVD MD can be provided during the entire period of the
performance evaluation study;
e) all legal requirements for performance evaluation studies are met;
f) the investigator(s) is (are) adequately skilled and trained to conduct the study and the necessary
resources are available.
4.2 Evaluation plan
The evaluation plan shall state the purpo on scientific, technical or medical grounds, the scope of
the evaluation, the structure and organization of the study and the number of devices concerned.
Defining the objective of the study, the co-ordinator shall have assd which performance claims
are already verified by data or scientific literature.
The evaluation plan shall be designed to minimi the requirements for invasive sampling. In the ca
of IVD MDs for lf-testing it shall be ensured that the evaluation plan is appropriate and acceptable to
urs and the information provided shall be clear and easily u18的英语
nderstood.
The evaluation plan shall specify
a) that the investigator(s) is (are) adequately skilled and trained to u the IVD MD;
b) the list of laboratories or other institutions taking part in the performance evaluation study; for lftesting,
the location and number of lay persons involved;
c) the time-table;
d) the necessary minimum number of probands from whom specimens are collected by invasive
procedures in order to adequately asss the performance of the IVD MD;
e) instructions for u including a description of the conditions of u;
f) the performance claims (e.g. analytical nsitivity, diagnostic nsitivity, analytical specificity,
diagnostic specif气候英语
icity, accuracy, repeatability, reproducibility) to be validated;
g) the format of performance study records.
4.3 Sites and resources
In general, the performance study procedure(s) shall be carried out under conditions reflecting the
relevant intended conditions of u.
The co-ordinator shall take the responsibility for the proper conduct of the performance evaluation
study at all sites. All investigators shall be named.
The co-ordinator shall ensure adequate competence and skill at all sites involved and that the
